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OpenTrials
Completed

NCT Number: NCT02044874

A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation

In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pharmacology Research Institute, Encino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged 18-65 years, inclusive
  • ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
  • Able to give signed informed consent
  • Eligible female patients will be:
  • non-pregnant
  • non-lactating
  • agree to use an acceptable method of effective contraception during the study
  • Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
  • Body weight of ≥50 kg (110 pounds), inclusive
  • Considered to be in stable health in the opinion of the investigator

Exclusion criteria

Patients who meet any of the following criteria will be excluded from the study.

  • Prior or current use of lorcaserin HCl
  • Prior participation in any study of a nicotine vaccination
  • Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
  • Use of tobacco products other than cigarettes
  • Prior use of fenfluramine or dexfenfluramine
  • Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
  • Previous participation in any clinical study within 6 weeks prior to the screening visit
  • History of severe allergies, severe drug or excipient allergy or hypersensitivity
  • History of significant cardiovascular condition
  • History of other significant medical conditions
  • Significant risk of suicide
  • Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
  • Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Recent history of alcohol or drug/solvent abuse
  • Concurrent participation in the study by more than one member of the same household
  • Not suitable to participate in the study in the opinion of the investigator

Treatment and study plan

APD356-lorcaserin hydrochloride

Drug

Other names: Belviq

Placebo

Drug

Primary outcomes

  1. Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12

    Time frame: Week 9 - Week 12

    Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm.

Secondary outcomes

  1. Abstinence During Weeks 3-12

    Time frame: Week 3 to Week 12

    The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm

  2. The 7 Day Point Prevalence or Weekly Abstinence at Week 8

    Time frame: Week 8

    The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm

  3. The 7 Day Point Prevalence or Weekly Abstinence at Week 12

    Time frame: Week 12

    The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm

  4. Body Weight

    Time frame: Baseline to Week 12

    Change in body weight from Week 1 (baseline) to Week 12

Sponsors and collaborators

Lead sponsor

Arena Pharmaceuticals

Industry

Registry information

Official study title

A 12-Week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel-group Phase 2 Dose Selection Study of Lorcaserin Hydrochloride, an Oral 5-HT2C Receptor Agonist for Smoking Cessation

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2014
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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